Kornimate/medical-research-clean huggingface dataset:
virological response study of the hcv vaccine ic41

Conditions: Chronic Hepatitis C

Summary: the objective is to investigate the virological (hcv-rna) responses following biweekly immunization with ic41. treatment phase 14 weeks, total study duration including follow-up period 38 weeks.


Eligibility criteria:
inclusion criteria: * written informed consent obtained prior to study entry * patients with chronic hepatitis c; genotype 1 * treatment naive patients * male and female, 18 to 55 years * presence of hla-a2 marker * mentally healthy * no clinically relevant pathological findings in any of the investigations at screening * treatment naive patients with chronic hepatitis c of genotype 1 exclusion criteria: * positive results in hiv, hbsag and hav-ag (igm) * other causes of chronic hepatitis * history of autoimmune diseases * previous vaccination with any prophylactic or therapeutic hepatitis c vaccine (in a clinical study) * active or passive vaccination 4 weeks before and during the entire study period * decompensated liver disease * history of severe hypersensitivity reactions and anaphylaxis * known allergic reactions to one of the components of the vaccine and imiquimod cream * clinically significant diseases which, in the opinion of the investigator, might lead to frequent hospitalization/medical attendance * malignancies * immunosuppressive therapy * pregnancy, lactation or breast-feeding * unwillingness to practice appropriate contraception * participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period * patients, who in the opinion of the investigator, might not be able to comply with the study protocol (e.g.: drug addiction, alcoholism)
antibacterial effect and clinical performance of chitosan modified glass ionomer

Conditions: Reversible Pulpitis; Pulpitis; Caries,Dental; Caries Class I; Caries; Dentin; Caries

Summary: the study is a randomized clinical trial that assesses the clinical success and the antibacterial effect on carious dentine of glass ionomer when modified with chitosan and/or titanium dioxide nano particles vs the control group of modification with chlorhexidine as control when used in primary molars

participants will be recruited from the acquitted to the clinic of pediatric dentistry department , faculty of dentistry of ain shams university. random allocation of the participants where indirect pulp capping is indicated so that modified glass ionomer would be used as the filling material. partial removal of caries is done then caries sample would be taken and sent for a microbiological evaluation and then, cavity dimensions is recoded, finally placement of the modified glass ionomer in the prepared cavity. in a total period of 9 months the patients will be followed every 3 months for clinical evaluation and in the final visit the filling would be removed and another bacterial sample would be taken for comparison, then a permanent filling is placed.

Eligibility criteria:
inclusion criteria: the teeth will be primary molars selected from patients presented to the outpatient clinic that are * healthy patients. * age: 4-8 years. * children having at least one primary molar with only occlusal caries having dentine lesions wide enough for the smallest excavator to enter (ø=0.9 mm). exclusion criteria: * teeth with pulp involvement, those suffering from pain, irreversible pulpits or pulp necrosis. * children with systemic diseases. * patients with history of active para-functional oral habits, xerostomia. * patients who will have difficulties in cooperating.

Keywords: glass ionomer chitosan titanium dioxide titanium dioxide nanoparticles chlorhexidine indirect pulp capping alternative restorative technique stepwise caries excavation antibacterial restorative incomplete caries removal primary molars early childhood caries
a single-center trial of intravitreous injections of macugen (pegaptanib sodium) given at least 7 days before vitrectomy secondary to tractional retinal detachment in proliferative diabetic retinopathy

Conditions: PDR

Summary: primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy. secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing oct and fundus photographs.


Eligibility criteria:
inclusion criteria: * subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy. exclusion criteria: * subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
berberine on the secretion of incretin

Conditions: Diabetes Mellitus

Summary: berberine (bbr) is the main active ingredient of the ancient chinese herb medicine coptis. the hypoglycemic effect of bbr has been demonstrated in numerous studies. although bbr is safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still unclear. jin-kui yang found that bbr can promote glp-1 secretion from intestinal l cells in mice in vitro and in vivo, thereby achieving the effect of lowering blood glucose, but it is still unknown whether bbr can promote incretin secretion in humans. in this study, investigators plan to examine the effect of bbr on secretion of incretin in human.


Eligibility criteria:
inclusion criteria: 1. voluntary participation in the trial and signed informed consent form. 2. healthy male subjects aged 18-45 years (including 18 and 45 years). 3. no history of current or former diseases such as heart, liver, kidney, gastrointestinal tract, nervous system, respiratory system, mental disorders and metabolic abnormalities that the investigator considers meaningful; no physical examination, electrocardiogram, and laboratory examination results abnormality or abnormality has no clinical significance (subject to the judgment of the physician). 4. body mass index of 18.0-25.0 kg/cm2 (including 18.0 and 25.0 kg/cm2) and no centripetal obesity (waist-to-hip ratio less than 0.9). 5. no family history of diabetes mellitus and obesity. 6. normal glucose tolerance (fasting blood glucose \<6.1 mmol/l and 2h blood glucose \<7.8mmol/l after oral administration of 75g glucose) and normal insulin secretion function (as judged by the investigator through the results of insulin release experiment). 7. able to communicate well with the investigator and complete the study in accordance with the study regulations. exclusion criteria: 1. infection with hepatitis (a, b, or c), hiv and syphilis. 2. those with clear allergy to berberine hydrochloride or its preparation components; those with drug (including salicylic acid) allergy, history of allergic diseases or allergic constitution. 3. patients with hemolytic anemia and glucose-6-phosphate dehydrogenase deficiency. 4. those who have used any prescription medication, herbal medicine within 4 weeks prior to dosing and/or taken over-the-counter medication (except for subjects with occasional or restricted use of paracetamol), supplements (except for routine vitamin supplementation) within 2 weeks prior to dosing. 5. cumulative amount of blood loss (eg. blood donation) over 400ml within 3 months prior to baseline visit and during the study. 6. heavy smokers (25 or more cigarettes per day) and heavy drinkers (14 units of alcohol per week, 1 unit = 285ml of beer, or 25ml of spirits, or 100ml of wine). 7. those with a history of substance abuse or positive urine test for prohibited drugs. 8. those who participated in any clinical trial within 1 month prior to the trial, or those who plan to participate in other clinical trials during or within 1 month after the end of the trial. 9. other circumstances that the investigator considers unsuitable for participation in this study.
ciprofloxacin in drug-resistant epilepsy

Conditions: Epilepsy Intractable

Summary: this study aims to investigate the effect of a short-term prescription of ciprofloxacin on intestinal microbial pattern and seizure frequency of patients with drug-resistant epilepsy.


Eligibility criteria:
inclusion criteria: * drug-resistant epilepsy with frequency of at least 2 seizure/week * acceptance of patients or his/her guardian (signing informed consent) exclusion criteria: * hypersensitivity to ciprofloxacin or other fluoroquinolones * history of tendon, renal, hepatic or cerebrovascular disease, organ transplantation or myasthenia gravis * usage of medications with interaction to ciprofloxacin * no reliable contraception * pregnancy or breastfeeding * being under treatment with corticosteroid * usage of antibiotics in recent 2 months or need to use it during the study * patients who are candidate for epilepsy surgery or other nonmedical treatments * change in anti-seizure medications (asms) during recent month * patients who will need changes in asms dose during study
carotid aneurysm registry

Conditions: Extracranial Carotid Artery Aneurysm

Summary: to prospectively collect data on ecaa we designed the carotid aneurysm registry (car). the aim of this study is to collect data on ecaa and its treatment to assess the natural history of ecaa and the success and safety of different treatment strategies.

car is a prospective observational study, initiated by the department of vascular surgery at university medical centre utrecht (umcu), the netherlands. the study is descriptive in nature. the registry will be conducted according to the principles of the declaration of helsinki (64th wma general assembly, fortaleza, brazil, october 2013). the medical ethics committee of the umcu has approved the study and all patients must give written informed consent before enrollment. study enrolment is open to any patient diagnosed with an ecaa and ongoing. enrollment criteria: participation in the car is intended for all subjects diagnosed with an ecaa irrespective of chosen treatment. aneurysms are defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm. to be included, aneurysms must be located in the cca, the external carotid artery or in the extracranial part of the ica.to be included in the registry, patients need to be 18 years old. there are no additional exclusion criteria. intervention and follow-up:car does not interfere with the physician's treatment decision. follow-up visits and imaging studies are scheduled as usual in their clinical practice, as this study does also not interfere with or influence the follow-up regimen. study endpoints:the primary endpoint of the car is freedom from aneurysm related symptoms at 30 days and at mid- and longterm follow-up. the secondary endpoint comprises treatment safety. endpoint monitoring:an endpoint adjudication committee, consisting of clinical experts, is set up to harmonize and standardize endpoint assessment and to determine whether the endpoints meet described criteria. this committee will review important subjective endpoints reported by trial investigators. the members of this committee are blinded to the treatment regime. data collection and monitoring: data collected will be recorded through a web-based case report form (crf). data will be collected at baseline, at the moment of intervention, at the 30-day (or first postoperative) visit and during the follow-up phase. data will remain at the umcu in a secure environment. this registry is a multicenter study. statistical analysis: statistical analyses will be performed using spss software.

Eligibility criteria:
inclusion criteria: * individual has one or more aneurysms of the extracranial carotid artery. defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm. * individual is ≥18 years of age. * individual has signed informed consent exclusion criteria: * none

Keywords: extracranial carotid artery aneurysm registry car
a post marketing surveillance on piqray in korea

Conditions: Breast Cancer

Summary: this is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of piqray in the real-world setting

the observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of piqray. if the subject does not return for a follow-up visit or stops taking piqray for any reason, all data collected until the date of the last contact of the subject will be used. patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.

Eligibility criteria:
inclusion criteria: subjects eligible for this study must meet all of the following criteria: 1. postmenopausal women and men who have a confirmed diagnosis of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3ca mutated, advanced or metastatic breast cancer. 2. patients who have progressed on prior endocrine based therapy and are going to start piqray treatment for the first time in accordance with the locally approved label. 3. patients who are willing to provide written informed consent exclusion criteria: subjects eligible for this study must not meet the following criteria: 1. patients with contraindication according to prescribing information for piqray in korea. - severe hypersensitivity to piqray or to any of its components 2. female subjects who are pregnant and nursing (lactating) 3. patients who are sexually active but not willing to follow contraceptive precautions during taking piqray. 4. participants who receive or are going to receive any investigational medicine during surveillance period.

Keywords: breast cancer nis piqray korea alpelisib
prospective registry to assess the cath lab percutaneous coronary intervention long-term outcomes: a single center

Conditions: Coronary Artery Disease

Summary: the registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.

the registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. the data are collected using an uploading system through internet.

Eligibility criteria:
inclusion criteria: * patients receiving coronal artery angiography or percutaneous coronary intervention therapy exclusion criteria: * none
epidemiology of sudden cardiac arrest in sub-saharan africa: rationale and design

Conditions: Cardiovascular Diseases

Summary: background the burden of sudden cardiac death (scd) in africa is unknown. our aim is to assess the epidemiology of scd in africa. methods the sub-saharan africa scd study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims \> 15 years old. investigators will use the definition of established scd if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable scd if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. after approval from institutional boards, investigators will record demographic, clinical, electrocardiographic and biological variables of scd victims (including survivors of cardiac arrest) in several sub-saharan african cities. all deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (sca) in various patient populations throughout countries. conclusion this study will provide comprehensive, contemporary data on the epidemiology of scd in sub-saharan africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.


Eligibility criteria:
inclusion criteria: * victims of cardiac arrest, either scd or aborted sca exclusion criteria: * age ≤ 15 years. * refusal of consent (by the family).
a phase i/ii trial of vb-111 and paclitaxel for recurrent platinum-resistant müllerian cancer

Conditions: Platinum Resistant Ovarian Cancer

Summary: this is a prospective, open label, dose escalating, phase i/ii study, measuring mainly the safety and tolerability of the combination of intravenous administration of vb-111 and paclitaxel in patients with platinum resistant ovarian cancer.


Eligibility criteria:
inclusion criteria: * patients aged \> 18 * histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (upsc), and gynecologic malignant mixed müllerian tumors (mmmts). * must have had prior platinum or platinum based therapy. * eastern cooperative oncology group (ecog) status 0-1. * platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen * measurable disease * adequate bone marrow and hematological function. * must have recovered from acute toxicity from prior treatment * prior treatment with an anti-angiogenic agent is not an exclusion criterion. * no prior gi perforation, or gi obstruction or involvement of the bowel on imaging * known hypersensitivity to cremophor el. however, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge. * no patients receiving other investigational therapy for the past 30 days before dosing. exclusion criteria: * more than 3 prior lines of chemotherapy for recurrent cancer. * history of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years. * life expectancy of less than 3 months * ctc grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes. * inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy. * new york heart association (nyha) grade ii or greater congestive heart failure. * history of myocardial infarction or unstable angina within 6 months prior to study day 1. * history of stroke or transient ischemic attack within 6 months prior to day 1. * known cns disease, except for treated brain metastasis * significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1. * history of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1. * evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
a phase 2 clinical trial of the safety and effects of irx-2 in treating patients with operable head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this was a phase 2a trial to investigate the safety and biological activity of the rix-2 regimen in patients with untreated, resectable squamous cell cancer of the head and neck (hnscc).

irx-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. irx-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including t cells, dendritic cells, and natural killer cells to recognize and destroy tumors. the present study administered the irx-2 regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the irx-2 regimen.

Eligibility criteria:
inclusion criteria: * pathologically confirmed (histology) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * no prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care. * clinically staged stage ii, iii, or iva cancer, assessed to be surgically resectable with curative intent. * life expectancy of greater than 6 months exclusion criteria: * stage ivb squamous cell carcinoma * use of any investigational agent within the previous 30 days * uncontrolled cardiovascular disease * myocardial infarction within the last 3 months * abnormal hemoglobin, neutrophil, lymphocyte or platelet counts * positive for hepatitis b or c or hiv * evidence of distant metastases * clinical gastritis or peptic ulcer within the last 6 months * stroke within the last six months

Keywords: head and neck cancer immunotherapy irx-2 mouth cancer throat cancer
strategies of self-management of endometriosis symptoms

Conditions: Endometriosis

Summary: to determine the prevalence and perceived utility of self-management strategies amongst patients with endometriosis and who consult the endometriosis clinic of the geneva university hospital, information about these strategies will be obtained via a web-based questionnaire.


Eligibility criteria:
inclusion criteria: * patients consulting at the endometriosis clinic of the hug * minimum 18 years * capacity to answer the questions of the questionnaire exclusion criteria: * minor patients